Patient leaflet - Zubrin
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zubrin 50 mg oral lyophilisates for dogs
Zubrin 100 mg oral lyophilisates for dogs
Zubrin 200 mg oral lyophilisates for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Tepoxalin
Tepoxalin
Tepoxalin
50 mg / oral lyophilisate 100 mg / oral lyophilisate 200 mg / oral lyophilisate
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral lyophilisates
4.
CLINICAL PARTICULARS
4.1
Target species
Dogs
4.2
Indications for use
Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
4.3 Contraindications
Do not use in pregnant or lactating dogs or in bitches intended for breeding.
Use is contraindicated in animals suffering from cardiac or hepatic disease, or where there is a history of gastrointestinal ulceration, or bleeding, or where there is hypersensitivity to the product.
Do not use in dehydrated, hypovolaemic or hypotensive dogs, as there is an increased risk of renal toxicity.
4.4 Special warnin
Special care should be taken when treating dogs with marked renal insufficiency.
Special pre
4.5 Special p
ns for use
for use in animals
Use in animals less than 6 months of age, with a weight below 5 kg, or in aged animals, may involve additisk. If such use cannot be avoided, close veterinary supervision to monitor for nal blood loss is necessary.
gas If
cts occur, treatment should be discontinued and the advice of a veterinary surgeon should commended dose should not be exceeded.
Special precautions to be taken by the person administering the medicinal product to animals
Tepoxalin is not water-soluble and becomes very sticky upon wetting. If the oral lyophilisate disintegrates prematurely, wash hands thoroughly.
In case of ingestion of a number of oral lyophilisates by a person, the advice of a doctor should b sought immediately.
4.6 Adverse reactions (frequency and seriousness)
Vomiting or diarrhoea may occur due to treatment. Alopecia and erythema may als occasionally.
Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/dia faeces, reduced appetite, lethargy and renal disorders. If there are such undesirable e should be discontinued immediately. In rare cases, particularly in older or in s undesirable effects may be serious or fatal.
During clinical trial testing of the product, the incidence of gastrointestinal rea (diarrhoea/vomiting) was 10%.
ea, blood in ts, treatment dogs, these
4.7 Use during pregnancy, lactation or lay
Do not use in pregnant or lactating bitches.
4.8 Interaction with other medicinal products and other forms of interaction
Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Other NSAIDs, diuretics, anticoagulants and substances with high plasma protein binding may compete for binding leading to potentially toxic effects.
4.9 Amounts to be administered and admini
route
10 mg tepoxalin per kg bodyweight once daily. clinical response. After a treatment perio evaluated in order to establish the need f under regular veterinary supervision.
The weight of the animal should be ac
termined before start of treatment.
e duration of treatment is dependent on days, the condition of the dog should be re-ation of treatment. Long term treatment should be
Peel back foil to reveal a single oral prevent the tablet from sticking to fi Place the tablet in the dog’s mouth.
mouth of the dog closed for a within 1–2 hours after feeding placed directly into the mouth moistened food, or in a moist consumed.
lyophilisate in the form of a round tablet. Ensure hands are dry to ingers. Push the bottom of the blister and the tablet will pop out. The tablet will disintegrate upon contact with moisture. Keep the econds to ensure complete tablet wetting. Administer to dogs n this is not possible, or when dogs resist having the product
ut the tablet immediately before administration into a small amount of at. Ensure the food or treat containing the medication is completely
4.10 Overdose
At doses of 30
ranging in c NSAID over appetite sus he blood.
ms, emergency procedures, antidotes)
sage is characterised by vomiting, soft faeces/diarrhoea, blood in faeces, reduced hargy. In the case of overdosage discontinue therapy. If gastrointestinal bleeding is inister gastric protectants. If vomiting continues, administer anti-emetics. Monitor the requently. Maintain the animal on intravenous fluids and, if necessary, administer whole
Withdrawal period
t applicable
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anti-inflammatory Products, Non Steroids ATCvet code: QM01AE92
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5.1 Pharmacodynamic properties
Tepoxalin is a dual cyclooxygenase / 5-lipoxygenase inhibitor with anti-inflammatory activity.
Oral administration of 10 mg tepoxalin / kg bodyweight results in inhibition of prostaglandin and leukotriene synthesis.
5.2 Pharmacokinetic properties
Tepoxalin is rapidly (Tmax of approximately 2 hours) absorbed after oral adm therapeutic dose of 10 mg/kg, the Cmax of tepoxalin was 1.08 ± 0.37 pg/ml in
and 1.19 ± 0.29 pg/ml in dogs fed a high fat meal. Absorption of tepoxal administration to dogs in a fed state. Tepoxalin is extensively converted acid metabolite is a potent, active cyclooxygenase inhibitor and prolong compound. Plasma concentrations of the acid metabolite are higher than in the dog. No accumulation of tepoxalin or its acid metabolite was dete a broad dose range. Tepoxalin and its metabolites are highly protein-bou and its metabolites are excreted in the faeces (99%).
inistration in dogs. At a dogs fed a low fat meal facilitated via acid metabolite. The activity of the parent
hose of the parent compound ed after multiple dosing over d, more than 98%. Tepoxalin
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6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Gelatin
Mannitol
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
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6.4 Special precautio
torage
This veterinary medicinal product does not require any special storage conditions.
Zubrin oral ly lyophilisates.
6.5 Nature an
sition of immediate packaging
are supplied in boxes with foil blisters. Each blister contains 10 oral
The oral lyophilisates are available in the following pack sizes:
20
ck sizes may be marketed.
g:
1 box containing 1 or 3 blisters.
1 box containing 1, 3 or 6 blisters.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medici products should be disposed of in accordance with the local requirements.
7. MARKETING AUTHORISATION HOLDER
Intervet International B. V.
Wim de Korverstraat 35 5831 AN Boxmeer The Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/00/028/002–008
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13 March 2001
10. DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal p Medicines Agency.
is available on the website of the European
Not applicable
PROHIBITION OF SALE, SUPPLY AND/OR USE
A.
MANUFACTURING AUTHORISATI BATCH RELEASE
B.
CONDITIONS OR RESTRICTI
REGARDING SUPPLY OR USE
ANNE
DER(S) RESPONSIBLE FOR
THE MARKETING AUTHORISATION
IONS OF THE MARKETING AUTHORISATION FFECTIVE USE
C.
D.
CONDITIONS OR REST
WITH REGARD TO SAF
STATEMENT OF THE
Name and address of the manufacturer responsible for batch release
To be supplied only on veterinary prescription.
Not applicable
Not applicable
S-P Veterinary Ltd Breakspear Road South Harefield
Uxbridge UB9 6LS United Kingdom
D. STATEMENT OF THE MRLs
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUT REGARDING SUPPLY OR USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETI REGARD TO THE SAFE AND EFFECTIVE USE OF
TION
THORISATION WITH ODUCT
50 mg / oral lyophilisate
caused by acute and chronic musculoskeletal disorders.
F ADMINISTRATION
-
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zubrin 50 mg oral lyophilisates for dogs
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Tepoxalin
-
3. PHARMACEUTICAL FORM
Oral lyophilisates
-
4. PACKAGE SIZE
10 oral lyophilisates (EU/2/00/028/002)
30 oral lyophilisates (EU/2/00/028/003)
-
5. TARGET SPECIES
Dogs
-
6. INDICATION(S)
Reduction of inflammation and reli
7. METHOD AND ROU
10 mg/kg of body weig daily.
The duration of treatm pendent on clinical response. After a treatment period of 7–10 days, the
condition of the dog sh re-evaluated in order to establish the need for continuation of treatment.
Long term treatment sh under regular veterinary supervision.
The weight of the animal should be accurately determined before start of treatment.
Administer to having the produ into a smal medicat
ithin 1–2 hours after feeding. When this is not possible, or when dogs resist laced directly into the mouth, put the tablet immediately before administration t of moistened food, or in a moist treat. Ensure the food or treat containing the pletely consumed.
Re
ckage leaflet before use.
8. SPECIAL WARNING(S), IF NECESSARY
Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers
Do not use in pregnant or lactating dogs or in bitches intended for breeding.
The recommended dose should not be exceeded.
If side effects occur, treatment should be discontinued and the advice of a veterinary surge be sought.
9. EXPIRY DATE
EXP {month/year}
10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUS WASTE MATERIALS, IF ANY
PRODUCTS OR
ch veterinary medicinal
ND CONDITIONS OR
D USE, if applicable
Any unused veterinary medicinal product or waste materials derive products should be disposed of in accordance with the local requirem
11. THE WORDS “FOR ANIMAL TREATMENT
RESTRICTIONS REGARDING SUPPLY
For animal treatment only – to be supplied only on veterinary prescription.
12. THE WORDS “KEEP OUT OF THE
AND SIGHT OF CHILDREN
Keep out of the reach and sight of children
Marketing Authorisation Hold
14. MARKE
THORISATION NUMBER(S)
13. NAME AND ADDRESS OF T
ARKETING AUTHORISATION HOLDER
Intervet International B. V.
Wim de Korverstraat 35 5831 AN Boxmeer The Netherlands
EU/2/00/028/002 (1 blister)
EU/2/00/028/003 (3 blisters)
mber}
FACTURER’S BATCH NUMBER
100 mg / oral lyophilisate
caused by acute and chronic musculoskeletal disorders.
F ADMINISTRATION
-
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zubrin 100 mg oral lyophilisates for dogs
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Tepoxalin
-
3. PHARMACEUTICAL FORM
Oral lyophilisates
-
4. PACKAGE SIZE
10 oral lyophilisates (EU/2/00/028/004)
30 oral lyophilisates (EU/2/00/028/005)
-
5. TARGET SPECIES
Dogs
-
6. INDICATION(S)
Reduction of inflammation and reli
7. METHOD AND ROU
10 mg/kg of body weig daily.
The duration of treatm pendent on clinical response. After a treatment period of 7–10 days, the
condition of the dog sh re-evaluated in order to establish the need for continuation of treatment.
Long term treatment sh under regular veterinary supervision.
The weight of the animal should be accurately determined before start of treatment.
Administer to having the produ into a smal medicat
ithin 1–2 hours after feeding. When this is not possible, or when dogs resist laced directly into the mouth, put the tablet immediately before administration t of moistened food, or in a moist treat. Ensure the food or treat containing the pletely consumed.
Re
ckage leaflet before use.
8. SPECIAL WARNING(S), IF NECESSARY
Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers
Do not use in pregnant or lactating dogs or in bitches intended for breeding.
The recommended dose should not be exceeded.
If side effects occur, treatment should be discontinued and the advice of a veterinary surge be sought.
9. EXPIRY DATE
EXP {month/year}
10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUS WASTE MATERIALS, IF ANY
PRODUCTS OR
ch veterinary medicinal
ND CONDITIONS OR
D USE, if applicable
Any unused veterinary medicinal product or waste materials derive products should be disposed of in accordance with the local requirem
11. THE WORDS “FOR ANIMAL TREATMENT
RESTRICTIONS REGARDING SUPPLY
For animal treatment only – to be supplied only on veterinary prescription.
12. THE WORDS “KEEP OUT OF THE
AND SIGHT OF CHILDREN
Keep out of the reach and sight of children
Marketing Authorisation Hold
14. MARKE
THORISATION NUMBER(S)
13. NAME AND ADDRESS OF T
ARKETING AUTHORISATION HOLDER
Intervet International B. V.
Wim de Korverstraat 35 5831 AN Boxmeer The Netherlands
EU/2/00/028/004 (1 blister)
EU/2/00/028/005 (3 blisters)
mber}
FACTURER’S BATCH NUMBER
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zubrin 200 mg oral lyophilisates for dogs
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Tepoxalin
n caused by acute and chronic musculoskeletal disorders.
200 mg / oral lyophilisate
3. PHARMACEUTICAL FORM
Oral lyophilisates
4. PACKAGE SIZE
10 oral lyophilisates (EU/2/00/028/006)
30 oral lyophilisates (EU/2/00/028/007)
60 oral lyophilisates (EU/2/00/028/008)
5. TARGET SPECIES
Dogs
6. INDICATION(S)
10 mg/kg of body weig The duration of treatme
Reduction of inflammation and r
7. METHOD AND RO
OF ADMINISTRATION
condition of the d Long term treatm The weight of the
shoul
aily.
pendent on clinical response. After a treatment period of 7–10 days, the re-evaluated in order to establish the need for continuation of treatment.
uld be under regular veterinary supervision.
l should be accurately determined before start of treatment.
Administer to dogs within 1–2 hours after feeding. When this is not possible, or when dogs resist having the product placed directly into the mouth, put the tablet immediately before administration into a small amount of moistened food, or in a moist treat. Ensure the food or treat containing the medication is completely consumed.
Re
ackage leaflet before use.
8. SPECIAL WARNING(S), IF NECESSARY
Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers
Do not use in pregnant or lactating dogs or in bitches intended for breeding.
The recommended dose should not be exceeded.
If side effects occur, treatment should be discontinued and the advice of a veterinary surge be sought.
9. EXPIRY DATE
EXP {month/year}
10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUS WASTE MATERIALS, IF ANY
PRODUCTS OR
ch veterinary medicinal
ND CONDITIONS OR
D USE, if applicable
Any unused veterinary medicinal product or waste materials derive products should be disposed of in accordance with the local requirem
11. THE WORDS “FOR ANIMAL TREATMENT
For animal treatment only – to be supplied only on veterinary prescription
AND SIGHT OF CHILDREN
12. THE WORDS “KEEP OUT OF THE
Keep out of the reach and sight of children
Marketing Authorisation Hold
14. MARKE
THORISATION NUMBER(S)
-
13. NAME AND ADDRESS OF T
ARKETING AUTHORISATION HOLDER
Intervet International B. V.
Wim de Korverstraat 35 5831 AN Boxmeer The Netherlands
EU/2/00/028/006 (1 blister)
EU/2/00/028/007 (3 blisters)
EU/2/00/028/008 (6 blisters)
UFACTURER’S BATCH NUMBER
15.
number}
MINIMUM PARTICULARS TO APPEAR ON BLISTER
{50mg}{100mg}{200mg}
Intervet International B. V.
EXP {month/year}
Batch {number}
For animal treatment only
Zubrin 50 mg oral lyophilisates for dogs
Zubrin 100 mg oral lyophilisates for dogs
Zubrin 200 mg oral lyophilisates for dogs Tepoxalin
2. NAME OF THE MARKETING AUTHORISATION HOLDER
3. EXPIRY DATE
4. BATCH NUMBER
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
5. THE WORDS “FOR ANIMAL TRE
T ONLY
PACKAGE LEAFLET
Zubrin oral lyophilisates for dogs
UCT
-
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR RELEASE, IF DIFFERENT
Marketing Authorisation Holder:
Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Manufacturer for the Batch Release:
S-P Veterinary Ltd Breakspear Road South Harefield
Uxbridge UB9 6LS United Kingdom
2. NAME OF THE VETERINARY MEDICINAL
Zubrin 50 mg oral lyophilisates for dogs
Zubrin 100 mg oral lyophilisates for dogs
Zubrin 200 mg oral lyophilisates for dogs
3. STATEMENT OF THE ACTIV
ANCE AND OTHER INGREDIENTS
Active substance
Tepoxalin
Tepoxalin
Tepoxalin mg / oral lyophilisate mg / oral lyophilisate mg / oral lyophilisate
4. INDICATIONS
Reduction of infl
n and relief of pain caused by acute and chronic musculoskeletal disorders.
5. CONT
CATIONS
Do not use if your dog
is pregnant or lactating or in bitches intended for breeding
has cardiac or hepatic disease
has had gastrointestinal ulceration or bleeding
is hypersensitive to the product
is dehydrated, hypovolaemic or hypotensive, as there is an increased risk of renal toxicity.
n
ADMINISTRATION
6. ADVERSE REACTIONS
Vomiting or diarrhoea may occur due to treatment. Alopecia and erythema may also occur occasionally.
Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarr faeces, reduced appetite, lethargy and renal disorders. If there are such undesirable effec should be discontinued immediately. In rare cases, particularly in older or in sensitive do undesirable effects may be serious or fatal.
During clinical trial testing of the product, the incidence of gastrointestinal reaction (diarrhoea/vomiting) occurred in 1 out of 10 animals.
If you notice any other side effects, please inform your veterinary surgeon.
7. TARGET SPECIES
Dogs
-
8. DOSAGE FOR EACH SPECIES, ROUTE AND METH
10 mg/kg once daily.
The weight of the animal should be accurately determined before start of treatment.
Peel back foil to reveal a single oral lyophilisate in the form of a round tablet. Push the bottom of the blister and the tablet will pop out. Place the tablet in outh. The tablet will disintegrate upon
contact with moisture. Keep the mouth of the dog closeew seconds to ensure complete tablet wetting. Administer to dogs within 1–2 hours after feed en this is not possible, or when dogs resist having the product placed directly into the mouth, put the tablet immediately before administration into a small amount of moistened food, or in a moist treat. Ensure the food or treat containing the medication is completely consumed.
9. ADVICE ON CORRECT ADM
The duration of treatment is dependent
TION
condition of the dog should be re Long term treatment should be un Ensure hands are dry to prevent t soluble and becomes very sticky hands thoroughly.
cal response. After a treatment period of 7–10 days, the ted in order to establish the need for continuation of treatment.
r regular veterinary supervision.
oral lyophilisate from sticking to fingers. Tepoxalin is not water-on wetting. If the oral lyophilisate disintegrates prematurely, wash
IOD
10. WITHDRAWA
Not applicable
11.
ORAGE PRECAUTIONS
Keep oeach and sight of children.
This ve medicinal product does not require any special storage conditions.
Do not use after the expiry date, which is stated on the blister.
12. SPECIAL WARNINGS
s,
on should
The recommended dose should not be exceeded.
Use in animals less than 6 months of age, with a weight below 5 kg, or in aged animals, may in additional risk. If such use cannot be avoided, close veterinary supervision to monitor for gastrointestinal blood loss is necessary.
Special care should be taken when treating dogs with marked renal insufficiency
Tepoxalin must not be administered in conjunction with other NSAIDs or glucoco diuretics or anticoagulants.
If side effects occur, treatment should be discontinued and the advice of a veterina be sought.
In case of ingestion of a number of oral lyophilisates by a person, the advice sought immediately.
r should be
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UN MATERIALS, IF ANY
RODUCT OR WASTE
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAF
LAST APPROVED